Manager

1 week ago

Vadodara, Gujarat, India Sun Pharmaceutical Industries Full time

Job Title CMC-IRAJob GradeG11B G11AFunction India Regulatory AffairsLocation BarodaJob SummaryReview of CMC documents Documents include but not limited to following Drug substance Structural formula molecular formula and relative molecular weight General description of raw materials Identification of critical steps in process and control Flow diagram of manufacturing process Description and characterization of drug substance Physiochemical data Chemical name and structure Empirical formula Molecular weight Physical properties - Description Solubility Rotation Partition coefficient Dissociation constant Analytical Data Elemental analysis Mass spectrum NMR spectra IR spectra UV spectra Polymorphic identification Complete monograph specification and STP Impurities name manufacturer Residual solvent other volatile impurities OVI estimation Manufacturing process for drug substance Validation of manufacturing process assay method impurity estimation method residual solvent other volatile impurities OVI estimation method Manufacturer s Stability of drug substance Tests and evaluation of packaging materials Specifications of primary and secondary packing Container closure system Reference standards Justification of specifications Storage and shipping conditions of drug substance Protocol of stability study results and conclusions Manufacturing process development Selection and justification of critical steps Filling procedure for the active ingredient in-process controls Stabilization of active ingredient Drug Product Justification of final qualitative quantitative formula Manufacture of drug product Description and composition of drug product Description of manufacturing process Protocol of stability study results and conclusions Stability of drug product Tests and evaluation of packaging materials Specifications of primary and secondary packing Container closure system Finished product specification and STP Justification of specifications Excipient compatibility study Dissolution Study In process quality control check and report Certificate of analysis Validation of analytical procedures Forced degradation study Process validation protocol and Report Labeling Details of equipment and facilities for production of drug product master formula batch record and set release documentation in respect of consistency batches Description of batch identification system Control of excipients adjuvant preservative stabilizers and others Use of new adjuvants preservatives stabilizers and excipients Areas Of Responsibility Checking of CMC documents Discussion with CFT for corrections Co-ordination for finalized CMC documents from stakeholders Review and approval of CCR Compilation of CMC dossier for regulatory submission including query responses Travel EstimateOnly if requiredJob ScopeInternal Interactions within the organization YesExternal Interactions outside the organization Yes in case of CMO projectsGeographical ScopeFinancial Accountability cost revenue with exclusive authority Job RequirementsEducational QualificationM PharmaSpecific CertificationExperience5-10 yearsSkill Functional Behavioural Knowledge of CMC requirements understanding of ICH quality guidelines

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